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Job Description
- Lead the efforts of QA personnel responsible for the testing, investigations, and method transfer activities to ensure compliance with all regulatory requirements, company policies, values, and goals
- Responsible for setting strategy direction for the Quality Assurance Dept. and team
- Support team by guidance and coaching and provide direction/approval of activities and decisions
- Share oversight to individuals and team on personal development, performance, and quality related issues. Write and deliver performance reviews
- Ensure proper use of assets, budget, and personnel and communicate effectively with key customers and partners, both within the site and outside as appropriate
- Responsible for supporting all planned and unplanned manufacturing and labs deviations, review and approval of product and equipment change controls (including SOPs and master batch records)
- Conduct impact assess to design changes and participate/coordinate CAPA Review Board
- Maintain the structure to ensure that all quality commitments and timelines are tracked and met. In addition, assist the senior leaders at the site in resource and budget preparations
- Responsible for driving process improvements within Drug Substance, Drug Product, Site support systems
- Actively with urgency when necessary to resolve issues related to production or supply as it relates to investigations or other issues
- Coordinate planned and/or ad-hoc external audits and drive Internal Audit plan and share reports and outcome to the Site Management Team proposing continuous improvement action plan
- Participates in the recruitment, selection, promotion, and performance management of QA employees
Job Requirements
- BS with in pharmacy or science.
- Eight to twelve years experience in pharmaceutical operations, including at least three years in overseeing QA compliance.
- Excellent English, verbal / written communication
- Ability to work well through others
- Excellent computer skills
